Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-11 @ 8:09 AM
Study NCT ID:
NCT05155566
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2021-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality data was collected up to 37.4 months post palbociclib combination treatment initiation (from the data recorded during 22 months approximately of retrospective observation period). Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs', 'description': 'Due to non-interventional nature of the study, data for non-SAEs and SAEs were not collected. The study was a retrospective study of existing medical records. There was no collection of adverse events in the study, so there is no report of adverse events in the results.', 'eventGroups': [{'id': 'EG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 574, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 273, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Rate at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Progression Free Rate at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Progression Free Rate at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Progression Free Rate at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '56.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000'}, {'value': '88.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Survival Rate at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '99.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. 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Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time From Palbociclib Initiation to Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '27.6'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '16.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'CR was defined as complete resolution of all visible disease per the treating physicians opinion.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time From Palbociclib Initiation to Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '19.4'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Follow-up Time Since Palbociclib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '37.4'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '36.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Supportive Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor 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'85', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Anti-depressants', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Opioid immediate release', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Other supportive care', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotics', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Nutritional support', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Granulocyte colony stimulating factors', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Antifungals', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell transfusion', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Pruritus/rash treatments', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Erythropoietin stimulating agents', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelet transfusions', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Antivirals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Number of participants who received supportive therapies during palbociclib treatment were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Participants could receive more than one supportive treatment.'}, {'type': 'PRIMARY', 'title': 'Duration of Ongoing Palbociclib Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '37.4'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '31.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration of Discontinued Palbociclib Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '27.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '25.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Therapies Received Post Palbociclib Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'title': 'Palbociclib / IBRANCE and Fulvestrant/FASLODEX', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE andFulvestrant/FASLODEX,Exemestane/AROMASIN,Methotrexate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Letrozole/FEMARA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE andFulvestrant/FASLODEX,Methotrexate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Tamoxifen/NOLVADEX,Methotrexate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE andLetrozole/ FEMARA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anastrozole/ARIMIDEX', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Capecitabine/XELODA', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Docetaxel/TAXOTERE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Docetaxel/TAXOTERE,Capecitabine / XELODA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Doxorubicin/ADRIAMYCIN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Doxorubicin/ADRIAMYCIN,Cyclophosphamide/CYTOXAN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Everolimus/AFINITOR andExemestane/AROMASIN', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Exemestane/AROMASIN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fulvestrant/FASLODEX', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gemcitabine/GEMZAR', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nab Paclitaxel/ABRAXANE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Paclitaxel/TAXOL', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Paclitaxel/TAXOL,Capecitabine / XELODA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Paclitaxel/TAXOL,Doxorubicin/ ADRIAMYCIN,Cyclophosphamide/CYTOXAN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Paclitaxel/TAXOL,Gemcitabine/ GEMZAR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/IBRANCE and Anastrozole /ARIMIDEX,Methotrexate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib/ IBRANCE and Exemestane / AROMASIN,Capecitabine/XELODA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Palbociclib / IBRANCE and Fulvestrant/FASLODEX,Ixabepilone /IXEMPRA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ribociclib / KISQALI and Exemestane / AROMASIN,Epirubicin /PHARMORUBICIN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tamoxifen / NOLVADEX', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tamoxifen / NOLVADEX,Doxorubicin / ADRIAMYCIN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Toremifene / FARESTON', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No treatment', 'categories': [{'measurements': [{'value': '482', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Number of participants who received therapies post palbociclib treatment were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted.'}, {'type': 'PRIMARY', 'title': 'Time From Palbociclib Initiation to First Dose Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '21.8'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '13.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration of Dose Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '106.0'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '21.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration of Cycle Delays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '35.0'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '31.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'FG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '574'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with hormone receptor (HR) positive/Human Epidermal Growth Factor Receptor 2 (HER2) negative advanced or metastatic breast cancer who received palbociclib in combination with aromatase inhibitor or fulvestrant as first-line therapy were observed. Data was collected retrospectively from participants medical records and evaluated over approximately 22 months of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palbociclib + Aromatase Inhibitor', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.'}, {'id': 'BG001', 'title': 'Palbociclib + Fulvestrant', 'description': 'Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'title': 'African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian-Indian subcontinent', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian - other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Chinese', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'Middle Eastern', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mixed race', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Afro-Caribbean', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Menopause Status at Palbociclib Initiation', 'classes': [{'title': 'Menopause Induced by LHRH Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Menopause Induced by Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Natural Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '483', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '717', 'groupId': 'BG002'}]}]}, {'title': 'Perimenopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Premenopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Menopause status at palbociclib initiation including menopause induced by Luteinizing hormone-releasing hormone (LHRH) suppression, menopause induced by surgery, natural menopause, perimenopausal and premenopausal were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Type of Insurance Plan', 'classes': [{'title': 'Argentina-Servicio de Salud Publico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Argentina-Seguridad Social', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}, {'title': 'Argentina-PrivadoPrepagas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-ISSSTE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-Sedena', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mexico- PEMEX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-Aseguradora privada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-IMSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-SSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Mexico-Aseguradoras privadas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Chile-FONASA (El Fondo Nacional de Salud)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Chile-ISAPRE (Instituciones de Salud Previsional)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Costa rica/Panama-CSS (Caja de seguridad social)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Costa rica/Panama-Aseguradora privada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Colombia-Contributive regime (POS-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Colombia-Subsidized regime (POS-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Colombia-Special regime (i.e. teacher or military)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Colombia-Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants according to the type of insurance plan was reported', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Positive Biomarker Status', 'classes': [{'title': 'BRCA1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'BRCA2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Androgen receptor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'ESR1 mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with positive status for following biomarkers: breast cancer type 1 (BRCA1) gene, breast cancer type 2 (BRCA2), androgen receptor and estrogen receptor 1 (ESR1) mutation were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Family History of Breast Cancer', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '614', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants according to their family history of breast cancer as yes, no and unknown were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Stage of Initial Breast Cancer', 'classes': [{'title': 'Stage 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants according to stage at initial breast cancer diagnosis is presented. Staging used was American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM), where Stage 0=noninvasive ductal carcinoma in situ; Stage 1= tumor size up to 2 centimeters (cm) and no lymph node involved; Stage 2= tumor size between 2 to 5 cm, cancer has spread to lymph nodes; Stage 3a= any size tumor, spread to 4 to 9 lymph nodes.; Stage 3b=tumor has spread to chest wall; Stage 3c= any size tumor, spread to 10 or more lymph nodes; Stage 4 (metastatic)= any size tumor has spread to other organs.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Metastases to Lymph Nodes', 'classes': [{'title': 'Lymph nodes, Regional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Lymph nodes, Distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with metastases to lymph nodes (regional and distal) were presented.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'Grade 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}]}, {'title': 'Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance status is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: Fully active; Grade 1: Restricted in physically strenuous activity but ambulatory; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: Capable of only limited self-care; Grade 4:Completely disabled and Grade 5: Dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG status were presented.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Diagnosis for Which Palbociclib Combination was Prescribed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants prescribed palbociclib combination treatment for advanced/metastatic breast cancer were presented.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Different Sites of Metastases', 'classes': [{'title': 'Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}]}, {'title': 'Lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}, {'title': 'Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Skin/soft tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'Ovary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Visceral disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}, {'title': 'Non-visceral disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants according to the sites of metastases was presented. Participant could have more than one site of metastases.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants With De novo and Recurrent Breast Cancer', 'classes': [{'title': 'De Novo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '356', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}, {'title': 'Recurrent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with de novo and recurrent breast cancer occurrence were reported', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation', 'classes': [{'title': 'Bradyarrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Cerebrovascular disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Congestive heart failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Chronic pulmonary disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Connective tissue disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes with end organ damage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes without end organ damage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Electrolyte abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}]}, {'title': 'Long QT syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mild liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Moderate to severe renal disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Myelosuppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Peptic ulcer disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Peripheral vascular disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Unstable angina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants with their comorbidities diagnosed within 12 months prior to palbociclib initiation were reported.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants Prescribed Palbociclib (Aromatase Inhibitor or Fulvestrant at First Line)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at Initial Breast Cancer Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Age at Advanced Breast Cancer (ABC)/Metastatic Breast Cancer (mBC) Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '797', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.4', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Time From Initial Breast Cancer Diagnosis to ABC/mBC Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '397.5'}, {'value': '25.1', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '246.7'}, {'value': '39.2', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '397.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Time from ABC/mBC Diagnosis to Palbociclib Initiation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '797', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '232.6'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '128.1'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '232.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'The date of palbociclib treatment initiation was the study baseline. Here, time from ABC/mBC diagnosis to palbociclib initiation was reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis', 'classes': [{'title': 'Adjuvant Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}, {'title': 'Adjuvant endocrine therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received adjuvant chemotherapy and adjuvant endocrine therapy for early breast cancer treatment were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Received Radiotherapy or Surgery', 'classes': [{'title': 'Radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}, {'title': 'Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '574', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '847', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who received radiotherapy and surgery for early breast cancer were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of adjuvant endocrine therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.7', 'spread': '25.4', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '22.4', 'groupId': 'BG001'}, {'value': '31.2', 'spread': '25.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of adjuvant endocrine therapy for early breast cancer treatment is presented.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Time Since end of Adjuvant Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data was not collected for this baseline measure'}, {'title': 'Time From Regimen Completion of Adjuvant Therapy to Diagnosis of ABC/mBC', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data was not collected for this baseline measure'}, {'title': 'Time From Initial Breast Cancer Diagnosis to Palbociclib Initiation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '397.5'}, {'value': '27.0', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '295.9'}, {'value': '15.3', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '397.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The date of palbociclib treatment initiation was the study baseline. Here, time from initial breast cancer diagnosis to palbociclib initiation was reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}, {'title': 'Time From Advanced/Metastatic Diagnosis to Palbociclib Initiation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '797', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '232.6'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '128.1'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '232.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'The date of palbociclib treatment initiation was the study baseline. Here, time from advanced/metastatic diagnosis to palbociclib initiation is reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Here, number anaylzed signifies participants evaluable for this baseline measure.'}], 'populationDescription': 'Full Analysis Set (FAS) comprised of participants for whom a complete medical record review was conducted.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-13', 'size': 3639866, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-11T17:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 847}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2021-12-09', 'resultsFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-15', 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Rate at Month 6', 'timeFrame': 'Month 6 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Progression Free Rate at Month 12', 'timeFrame': 'Month 12 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Progression Free Rate at Month 18', 'timeFrame': 'Month 18 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Progression Free Rate at Month 24', 'timeFrame': 'Month 24 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.'}, {'measure': 'Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation', 'timeFrame': '1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.'}, {'measure': 'Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation', 'timeFrame': '2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.'}, {'measure': 'Clinical Benefit Rate', 'timeFrame': 'From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \\>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.'}, {'measure': 'Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib', 'timeFrame': 'From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.'}, {'measure': 'Survival Rate at Month 6', 'timeFrame': 'Month 6 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Survival Rate at Month 12', 'timeFrame': 'Month 12 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Survival Rate at Month 18', 'timeFrame': 'Month 18 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Survival Rate at Month 24', 'timeFrame': 'Month 24 (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.'}, {'measure': 'Time From Palbociclib Initiation to Initial Response Recorded', 'timeFrame': 'From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \\>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.'}, {'measure': 'Time From Palbociclib Initiation to Complete Response', 'timeFrame': 'From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'CR was defined as complete resolution of all visible disease per the treating physicians opinion.'}, {'measure': 'Time From Palbociclib Initiation to Partial Response', 'timeFrame': 'From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.'}, {'measure': 'Follow-up Time Since Palbociclib Initiation', 'timeFrame': 'From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}, {'measure': 'Number of Participants With Supportive Therapies', 'timeFrame': 'From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Number of participants who received supportive therapies during palbociclib treatment were reported.'}, {'measure': 'Duration of Ongoing Palbociclib Treatment', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}, {'measure': 'Duration of Discontinued Palbociclib Treatment', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}, {'measure': 'Number of Participants According to Therapies Received Post Palbociclib Treatment', 'timeFrame': 'Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)', 'description': 'Number of participants who received therapies post palbociclib treatment were reported.'}, {'measure': 'Time From Palbociclib Initiation to First Dose Reduction', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}, {'measure': 'Duration of Dose Interruption', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}, {'measure': 'Duration of Cycle Delays', 'timeFrame': 'Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)'}]}, 'conditionsModule': {'keywords': ['human epidermal growth factor receptor 2 negative (HER2-)', 'hormone receptor positive (HR+)', 'advanced breast cancer (ABC)', 'metastatic breast cancer (MBC)'], 'conditions': ['Breast Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A5481125', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective medical data review of patients who have received palbociclib combination treatments as first line treatment regardless of combination partner and labelled use in Argentina, Chile, Peru, Mexico and a combined sample in Costa Rica and Panama.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Physician inclusion criteria:\n\n* Oncologist or gynecologist.\n* Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.\n* Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.\n\nPatient inclusion criteria:\n\n* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.\n* Received palbociclib as a first line therapy.\n* No prior or current enrolment in an interventional clinical trial for ABC/MBC.\n* Minimum of six months of follow up data since palbociclib initiation.\n\nPhysician exclusion criteria:\n\n* Qualified less than 2 years ago or more than 35 years ago.\n* Participated in observational research for ABC/MBC in the last 3 months.\n* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.'}, 'identificationModule': {'nctId': 'NCT05155566', 'briefTitle': 'Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HORMONE RECEPTOR POSITIVE/ HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HR+/HER2-) Advanced/Metastatic Breast Cancer In Real World Settings', 'orgStudyIdInfo': {'id': 'A5481125'}, 'secondaryIdInfos': [{'id': 'IRIS LATAM', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Patients', 'description': 'HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer country office', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'SK105JB', 'city': 'Bollington', 'state': 'Chesshire', 'country': 'United Kingdom', 'facility': 'Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK', 'geoPoint': {'lat': 53.29446, 'lon': -2.10963}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}